0 1990 S. Karger AG, Basel 0042-9007/90/0591-0026 $2.75/0
Vox Sang 1990;59:26-29
Prevalence of Hepatitis C Virus Antibodies in Italian Blood Donors G . Sirchia, D . Almini, A . Bellobuono, A . M . Giovanetti, M. Marconi, E Mercuriali, E Mozzi, A . Parravicini, M. Pizzi, E Zanuso and the Italian Cooperative Group‘ Centro Trasfusionale e di Imrnunologia dei Trapianti, Ospedale Maggiore, Milano, Italia
Abstract. 11,117 blood donors from 24 blood transfusion services evenly distributed throughout the various Italian regions were tested for the presence of hepatitis C virus (HCV) antibodies in the serum and serum alanine aminotransferase (ALT) level. The results are as follows: (1) anti-HCV seroprevalence in Italy was 0.87% with a difference between Northern and Southern regions (0.68 vs. 1.37%) and between younger and older subjects (0.62 vs. 1.21%); (2) prevalence of elevated ALT levels was 4.74% without a North-South effect (except than for markedly elevated ALT levels); (3) anti-HCV seroprevalence was higher in subjects with elevated ALT (5.0%),with a North-South effect (2.2 vs. 9.9%) and particularly high (19.2%) in subjects with markedly elevated ALT; (4) ALT levels were elevated in 26.2% of anti-HCV positive subjects, with a North-South effect (14 vs. 40.5%).
Viral hepatitis is a serious complication of blood transfusion that still occurs in 2-14% of transfused patients in North America and Western Europe [l, 21. In most cases, posttransfusion hepatitis is due to the non-A, non-B (NANB) viruses [3]. Until recently, no specific test was available to detect these viruses, and measures to prevent their transmission by blood still consist only of applying indirect criteria for blood donor exclusion, including elevated serum alanine aminotransferase (ALT) levels and the presence of anti-HBc antibodies in the serum. Recently, a blood-borne NANB hepatitis agent, designated hepatitis C virus (HCV), has been isolated [4] and a recombinantbased immunoassay for the detection of HCV antibodies developed. To determine the prevalence of these antibod-
ies in Italian blood donors, a multicenter cooperative study was carried out, and we now report the results of this investigation.
I
Blood Donors All the 11,117subjects included in the study were volunteers and met the Italian regulations for blood donation. First-time donors were a rather inhomogenous group, since blood transfusion services located in touristic areas bled persons coming from various parts of Italy and from abroad for their holidays. Moreover, first-time donors were selected on their history so as to exclude those at high risk.
C. Artaz (Aosta), G. Avanzi (Firenze), E Biffoni (Udine), G. Canali (Bussolengo VR), F. Cappi (Bologna), P. Coser (Bolzano), F. D’Agostino (Lodi MI), S . D’Angelo (Melfi PZ), G. De Stasio (Carbonara BA), D. Dimonte (Bari), G. Galfano (Palermo), L. Galiano (Catanzaro), C. Gambelunghe (Perugia), G. C. Isacchi (Roma), M. Licenziati (Brescia), A. Massaro (Torino), G.Ongaro (Padova), E.Passarelli Pula (Macerata), G. Reali (Genova), G. L. Romanini (Cremona), M. Rubertelli (Trento), G. Sirchia (Milano), A. Stangoni (Sassari), C.Vacca (Napoli).
Materials and Methods Study Design ’henty-four blood transfusion services evenly distributed throughout the country participated in this cooperative study, evaluating a mean of 463 blood donors each (range 232-1,064). Tests were carried out in July and August 1989 and results were forwarded for analysis to the Transfusion Center of Milano along with some other information about the donor: age and sex; type of donor (first time or repeat); ALT level, given as normal, higher than the upper reference value but less than twice this level (slightly elevated), more than twice the upper reference value (markedly elevated).
Anti-HCV Seroprevalence in Italian Donors
27
Table 1. Demographic data of the population studied ~
~~
~_________
Blood donors, n Maleslfemales Repeat/first time Mean age, years Transfusion services, n Donors per service, mean n
Whole group
North
South
11,117 4.3 2.21 37 24 463
8,068 4.0 4.17 38 17 474
3,049 5.2 0.60 34 7 435
Table 2. Anti-HCV seroprevalence in Italian blood donors
All donors First time donors Repeat donors Males Females
Whole group
North
South
0.87 (97/11,117) 1.10 (38/3,467) 0.77 (59/7,650) 0.84 (76/9,005) 1.00 (21/2,098)
0.68 (598,068) 0.64 (10/1,561) 0.69 (45/6,507) 0.63 (41/6,447) 0.87 (14/1,614)
1.37 (4213,049) 1.47 (2811,906) 1.22 (14/1,143) 1.37 (35/2,558) 1.44 (7/484)
Fig. 1. Anti-HCV seroprevalence in different age groups.
Methods HCV antibodies were detected by the HCV Antibody ELISA Test System, Ortho Diagnostic Systems, Raritan, N.J., USA. Positive results were repeated on the same serum sample and repeatedly reactive samples were defined as positive. Serum ALT activity was measured by spectrophotometry. Statistical methods included the x2 and one-tailed Fisher’s exact tests.
Results Demographic data of the population studied are reported in table 1. There was a predominance of males and repeat donors. When Northern regions were compared to Southern regions, the ratio repeadfirst-time donors was significantly different (4.17 vs. 0.60; p < 0.01). Data on anti-HCV seroprevalence are summarized in table 2. Anti-HCV seroprevalence of the whole group was 0.87%. It was higher in females than in males and in firsttime than repeat donors, although not significantly so. Anti-HCV seroprevalence increased with age (fig. 1); a significant difference was found between younger (18-38 years) and older (39-65 years) subjects (0.62 vs. 1.21; p < 0.01). Seroprevalence for the various regions investigated is reported in figure 2. It varied from 0% in Marche to 1.73% in Campania, being 0.68% in Northern regions and 1.37% in Southern regions (p < 0.01). This North-South difference
Fig.2. Anti-HCV seroprevalence in the Italian regions investigated.
was present even when repeat blood donors only were considered. Figure 3 reports the prevalence in the various regions of blood donors with elevated ALT. Out of the 8,868 fully evaluable blood donors, 421 (4.74%) had elevated ALT levels: 369 (4.2%) slightly elevated (median 55 U/1, range 38-86), 52 (0.6%) markedly elevated (median 107, range 65-260). A clear North-South effect was not present when all subjects with elevated ALT were considered, but be-
28
Sirchia/Almini/Bellobuono/Giovanetti/Marconi~ercu~ali/Mozzi/Parravic~ni~izz~Zanuso/Ital~an Cooperative Group
Table 3. Anti-HCV seroprevalence and ALT in the Italian blood donors examined ALT
Anti-HCV prevalence
Normal Elevated Slightly elevated Markedly elevated
whole group
North
South
59/8,447 (0.7) 21/421 (5.0) 111369 (3.0) 10/52 (19.2)
37/5,982 (0.6) 6/270 (2.2) 3/249 (1.2) 3/21 (14.3)
22/2,465 (0.9) 15/151 (9.9) 81120 (6.7) 7/31 (22.6)
Table 4. Elevated ALT prevalence and anti-HCV status in the Italian blood donors examined Anti-HCV status
Negative Positive
Elevated ALT prevalence whole group
North
South
400/8,788 (4.5) 21/80 (26.2)
264/6,209 (4.2) 6/43 (13.9)
136/2,579 (5.3) 15/37 (40.5)
Fig. 3. Elevated ALT prevalence in the Italian regions investigated.
came apparent when only those with more elevated ALT were taken into account (North 0.33%, South 1.18%, p
Vox Sang 1990;59:26-29
Prevalence of Hepatitis C Virus Antibodies in Italian Blood Donors G . Sirchia, D . Almini, A . Bellobuono, A . M . Giovanetti, M. Marconi, E Mercuriali, E Mozzi, A . Parravicini, M. Pizzi, E Zanuso and the Italian Cooperative Group‘ Centro Trasfusionale e di Imrnunologia dei Trapianti, Ospedale Maggiore, Milano, Italia
Abstract. 11,117 blood donors from 24 blood transfusion services evenly distributed throughout the various Italian regions were tested for the presence of hepatitis C virus (HCV) antibodies in the serum and serum alanine aminotransferase (ALT) level. The results are as follows: (1) anti-HCV seroprevalence in Italy was 0.87% with a difference between Northern and Southern regions (0.68 vs. 1.37%) and between younger and older subjects (0.62 vs. 1.21%); (2) prevalence of elevated ALT levels was 4.74% without a North-South effect (except than for markedly elevated ALT levels); (3) anti-HCV seroprevalence was higher in subjects with elevated ALT (5.0%),with a North-South effect (2.2 vs. 9.9%) and particularly high (19.2%) in subjects with markedly elevated ALT; (4) ALT levels were elevated in 26.2% of anti-HCV positive subjects, with a North-South effect (14 vs. 40.5%).
Viral hepatitis is a serious complication of blood transfusion that still occurs in 2-14% of transfused patients in North America and Western Europe [l, 21. In most cases, posttransfusion hepatitis is due to the non-A, non-B (NANB) viruses [3]. Until recently, no specific test was available to detect these viruses, and measures to prevent their transmission by blood still consist only of applying indirect criteria for blood donor exclusion, including elevated serum alanine aminotransferase (ALT) levels and the presence of anti-HBc antibodies in the serum. Recently, a blood-borne NANB hepatitis agent, designated hepatitis C virus (HCV), has been isolated [4] and a recombinantbased immunoassay for the detection of HCV antibodies developed. To determine the prevalence of these antibod-
ies in Italian blood donors, a multicenter cooperative study was carried out, and we now report the results of this investigation.
I
Blood Donors All the 11,117subjects included in the study were volunteers and met the Italian regulations for blood donation. First-time donors were a rather inhomogenous group, since blood transfusion services located in touristic areas bled persons coming from various parts of Italy and from abroad for their holidays. Moreover, first-time donors were selected on their history so as to exclude those at high risk.
C. Artaz (Aosta), G. Avanzi (Firenze), E Biffoni (Udine), G. Canali (Bussolengo VR), F. Cappi (Bologna), P. Coser (Bolzano), F. D’Agostino (Lodi MI), S . D’Angelo (Melfi PZ), G. De Stasio (Carbonara BA), D. Dimonte (Bari), G. Galfano (Palermo), L. Galiano (Catanzaro), C. Gambelunghe (Perugia), G. C. Isacchi (Roma), M. Licenziati (Brescia), A. Massaro (Torino), G.Ongaro (Padova), E.Passarelli Pula (Macerata), G. Reali (Genova), G. L. Romanini (Cremona), M. Rubertelli (Trento), G. Sirchia (Milano), A. Stangoni (Sassari), C.Vacca (Napoli).
Materials and Methods Study Design ’henty-four blood transfusion services evenly distributed throughout the country participated in this cooperative study, evaluating a mean of 463 blood donors each (range 232-1,064). Tests were carried out in July and August 1989 and results were forwarded for analysis to the Transfusion Center of Milano along with some other information about the donor: age and sex; type of donor (first time or repeat); ALT level, given as normal, higher than the upper reference value but less than twice this level (slightly elevated), more than twice the upper reference value (markedly elevated).
Anti-HCV Seroprevalence in Italian Donors
27
Table 1. Demographic data of the population studied ~
~~
~_________
Blood donors, n Maleslfemales Repeat/first time Mean age, years Transfusion services, n Donors per service, mean n
Whole group
North
South
11,117 4.3 2.21 37 24 463
8,068 4.0 4.17 38 17 474
3,049 5.2 0.60 34 7 435
Table 2. Anti-HCV seroprevalence in Italian blood donors
All donors First time donors Repeat donors Males Females
Whole group
North
South
0.87 (97/11,117) 1.10 (38/3,467) 0.77 (59/7,650) 0.84 (76/9,005) 1.00 (21/2,098)
0.68 (598,068) 0.64 (10/1,561) 0.69 (45/6,507) 0.63 (41/6,447) 0.87 (14/1,614)
1.37 (4213,049) 1.47 (2811,906) 1.22 (14/1,143) 1.37 (35/2,558) 1.44 (7/484)
Fig. 1. Anti-HCV seroprevalence in different age groups.
Methods HCV antibodies were detected by the HCV Antibody ELISA Test System, Ortho Diagnostic Systems, Raritan, N.J., USA. Positive results were repeated on the same serum sample and repeatedly reactive samples were defined as positive. Serum ALT activity was measured by spectrophotometry. Statistical methods included the x2 and one-tailed Fisher’s exact tests.
Results Demographic data of the population studied are reported in table 1. There was a predominance of males and repeat donors. When Northern regions were compared to Southern regions, the ratio repeadfirst-time donors was significantly different (4.17 vs. 0.60; p < 0.01). Data on anti-HCV seroprevalence are summarized in table 2. Anti-HCV seroprevalence of the whole group was 0.87%. It was higher in females than in males and in firsttime than repeat donors, although not significantly so. Anti-HCV seroprevalence increased with age (fig. 1); a significant difference was found between younger (18-38 years) and older (39-65 years) subjects (0.62 vs. 1.21; p < 0.01). Seroprevalence for the various regions investigated is reported in figure 2. It varied from 0% in Marche to 1.73% in Campania, being 0.68% in Northern regions and 1.37% in Southern regions (p < 0.01). This North-South difference
Fig.2. Anti-HCV seroprevalence in the Italian regions investigated.
was present even when repeat blood donors only were considered. Figure 3 reports the prevalence in the various regions of blood donors with elevated ALT. Out of the 8,868 fully evaluable blood donors, 421 (4.74%) had elevated ALT levels: 369 (4.2%) slightly elevated (median 55 U/1, range 38-86), 52 (0.6%) markedly elevated (median 107, range 65-260). A clear North-South effect was not present when all subjects with elevated ALT were considered, but be-
28
Sirchia/Almini/Bellobuono/Giovanetti/Marconi~ercu~ali/Mozzi/Parravic~ni~izz~Zanuso/Ital~an Cooperative Group
Table 3. Anti-HCV seroprevalence and ALT in the Italian blood donors examined ALT
Anti-HCV prevalence
Normal Elevated Slightly elevated Markedly elevated
whole group
North
South
59/8,447 (0.7) 21/421 (5.0) 111369 (3.0) 10/52 (19.2)
37/5,982 (0.6) 6/270 (2.2) 3/249 (1.2) 3/21 (14.3)
22/2,465 (0.9) 15/151 (9.9) 81120 (6.7) 7/31 (22.6)
Table 4. Elevated ALT prevalence and anti-HCV status in the Italian blood donors examined Anti-HCV status
Negative Positive
Elevated ALT prevalence whole group
North
South
400/8,788 (4.5) 21/80 (26.2)
264/6,209 (4.2) 6/43 (13.9)
136/2,579 (5.3) 15/37 (40.5)
Fig. 3. Elevated ALT prevalence in the Italian regions investigated.
came apparent when only those with more elevated ALT were taken into account (North 0.33%, South 1.18%, p
